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ESS01: Essentials of EU and US Regulatory Affairs for Human Medicinal Products

By Zenosis

This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed.

ESS01: Essentials of EU and US Regulatory Affairs for Human Medicinal Products
Delivered Online On Demand3 hours
£99

Essential Components of European Medical Device Regulations

By Online Training Academy

Unlock the secrets to navigating the intricate landscape of European medical device regulations with our comprehensive course. Designed for those who seek mastery in understanding and applying the latest EU standards, this course is your gateway to compliance excellence. Dive deep into the regulatory environment, where you'll explore the essential components that govern the medical device industry in Europe. Learn how to seamlessly integrate these regulations into your practice, ensuring your products meet the highest standards of safety and efficacy. Key Features: CPD Certified Free Certificate from Reed CIQ Approved Developed by Specialist Lifetime Access Discover the nuances of reporting requirements and identification processes, critical for maintaining transparency and accountability. Our expertly curated content guides you through establishing a robust quality system, pivotal for regulatory success. Equip yourself with the knowledge to confidently manage regulatory submissions and navigate quality audits with ease. Join a community of like-minded professionals and elevate your regulatory expertise, ensuring your organisation stays ahead in the competitive medical device market. Enrol now to transform your approach to European medical device regulations and lead with confidence in a compliant and efficient manner. Course Curriculum Module 01: Overview to European Regulations on Medical Devices Module 02: Essential Components of EU MDR Module 03: Reporting Requirements and Identification Module 04: Quality System in Medical Device Regulation Learning Outcomes: Understand the core elements of European medical device regulations. Identify key components of EU Medical Device Regulation (MDR). Master reporting requirements and device identification processes. Implement quality systems in medical device regulation. Analyse essential EU MDR regulatory requirements. Navigate the complexities of EU medical device compliance. CPD 10 CPD hours / points Accredited by CPD Quality Standards Essential Components of European Medical Device Regulations 1:45:07 1: Module 01: Overview to European Regulations on Medical Devices 33:17 2: Module 02: Essential Components of EU MDR 29:12 3: Module 03: Reporting Requirements and Identification 16:21 4: Module 04: Quality System in Medical Device Regulation 25:17 5: CPD Certificate - Free 01:00 Who is this course for? Regulatory affairs specialists in the medical device industry. Quality assurance professionals in healthcare. Compliance officers in medical device companies. Medical device product managers. Legal advisors in healthcare regulation. Career path Regulatory Affairs Specialist Quality Assurance Manager Compliance Officer Medical Device Consultant Product Manager Regulatory Affairs Associate Certificates Digital certificate Digital certificate - Included Reed Courses Certificate of Completion Digital certificate - Included Will be downloadable when all lectures have been completed.

Essential Components of European Medical Device Regulations
Delivered Online On Demand1 hour 48 minutes
£12

Professional Certificate Course in Regulations and Policies in the Global Healthcare Industry in London 2024

4.9(261)

By Metropolitan School of Business & Management UK

The course focuses on understanding and navigating the complex landscape of regulations and policies in the global healthcare sector to ensure the delivery of safe, effective, and high-quality healthcare services. This course aims to examine policies ensuring top-tier healthcare provision, targeting healthcare professionals, policy analysts, regulatory affairs specialists, and public health administrators. After the successful completion of the course, you will be able to learn about the following, Analyze the influence of key regulations and policies shaping the global healthcare industry. Assess the contributions of government agencies and international organizations in shaping the global healthcare landscape. Discuss challenges and opportunities within global healthcare regulations and policies. Evaluate ethical and social implications in global healthcare regulations and policies. Develop a framework for assessing the effectiveness of regulations and policies in global healthcare. Recommend strategies to enhance regulations for equitable access to quality healthcare. Regulations and innovations in the global healthcare market are intricately linked, impacting technology, market dynamics, and the landscape of healthcare delivery and innovation. Course Structure and Assessment Guidelines Watch this video to gain further insight. Navigating the MSBM Study Portal Watch this video to gain further insight. Interacting with Lectures/Learning Components Watch this video to gain further insight. Regulations and Policies in the Global Healthcare Industry Self-paced pre-recorded learning content on this topic. Regulations And Policies In The Global Healthcare Industry Put your knowledge to the test with this quiz. Read each question carefully and choose the response that you feel is correct. All MSBM courses are accredited by the relevant partners and awarding bodies. Please refer to MSBM accreditation in about us for more details. There are no strict entry requirements for this course. Work experience will be added advantage to understanding the content of the course. The certificate is designed to enhance the learner's knowledge in the field. This certificate is for everyone eager to know more and get updated on current ideas in their respective field. We recommend this certificate for the following audience. Healthcare practitioners Policy analysts Regulatory affairs experts Public health administrators seeking expertise in global healthcare regulations and policies Average Completion Time 2 Weeks Accreditation 3 CPD Hours Level Advanced Start Time Anytime 100% Online Study online with ease. Unlimited Access 24/7 unlimited access with pre-recorded lectures. Low Fees Our fees are low and easy to pay online.

Professional Certificate Course in Regulations and Policies in the Global Healthcare Industry in London 2024
Delivered Online On Demand14 days
£27

Essentials of European Medical Device Regulations

4.5(3)

By Studyhub UK

Delve into the intricacies of European medical device regulatory frameworks with our comprehensive course, 'Essentials of European Medical Device Regulations.' This meticulously structured program provides an in-depth exploration of the critical components and legislative requirements necessary for navigating the complex landscape of medical device regulations in Europe. The first module introduces the foundational aspects of the European regulations, setting the stage for a deeper understanding of the legal and procedural elements that govern this sector. As the course progresses, participants will gain a thorough grasp of the Essential Components of EU MDR (Module 2), the pivotal aspects of Reporting Requirements and Identification (Module 3), and the integral role of Quality Systems in medical device regulation (Module 4). This course is meticulously designed to cater to the needs of professionals seeking a robust understanding of the regulatory environment, ensuring they are well-equipped to adhere to and implement these critical regulations. Learning Outcomes Acquire a solid foundation in the basic principles and framework of European regulations on medical devices. Understand the key elements of the EU Medical Device Regulation (MDR) and their application in the industry. Gain insights into the specific requirements for reporting and identification within the European regulatory context. Learn about the implementation and management of quality systems in compliance with medical device regulations. Develop the ability to interpret and apply regulatory guidelines in professional settings, enhancing compliance and operational efficiency. Why choose this Essentials of European Medical Device Regulations course? Unlimited access to the course for a lifetime. Opportunity to earn a certificate accredited by the CPD Quality Standards and CIQ after completing this course. Structured lesson planning in line with industry standards. Immerse yourself in innovative and captivating course materials and activities. Assessments designed to evaluate advanced cognitive abilities and skill proficiency. Flexibility to complete the Course at your own pace, on your own schedule. Receive full tutor support throughout the week, from Monday to Friday, to enhance your learning experience. Unlock career resources for CV improvement, interview readiness, and job success. Who is this Essentials of European Medical Device Regulations course for? Professionals in the medical device industry seeking to deepen their understanding of EU regulations. Regulatory affairs specialists aiming to stay updated with the latest European legislative changes. Quality assurance personnel in the healthcare sector requiring knowledge of regulatory compliance. Medical device manufacturers and distributors needing to align their products with EU standards. Healthcare consultants and advisors focusing on European medical device regulatory frameworks. Career path Regulatory Affairs Manager: £40,000 - £60,000 Quality Assurance Specialist: £35,000 - £50,000 Compliance Officer: £30,000 - £45,000 Product Development Engineer: £33,000 - £55,000 Healthcare Consultant: £45,000 - £70,000 Medical Device Auditor: £37,000 - £53,000 Prerequisites This Essentials of European Medical Device Regulations does not require you to have any prior qualifications or experience. You can just enrol and start learning. This course was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection. Certification After studying the course materials, there will be a written assignment test which you can take at the end of the course. After successfully passing the test you will be able to claim the pdf certificate for £4.99 Original Hard Copy certificates need to be ordered at an additional cost of £8. Course Curriculum Module 1: Overview to European Regulations on Medical Devices Overview to European Regulations on Medical Devices 00:43:00 Module 2: Essential Components of EU MDR Essential Components of EU MDR 00:40:00 Module 3: Reporting Requirements and Identification Reporting Requirements and Identification 00:27:00 Module 4: Quality System in Medical Device Regulation Quality System in Medical Device Regulation 00:36:00

Essentials of European Medical Device Regulations
Delivered Online On Demand2 hours 26 minutes
£10.99

Essentials EU Medical Device Regulations

5.0(1)

By Course Gate

Explore the essentials of European Medical Device Regulations (EU MDR) with our comprehensive course. Gain insights into regulatory requirements, quality systems, and reporting protocols to ensure compliance in the healthcare industry.

Essentials EU Medical Device Regulations
Delivered Online On Demand3 hours 6 minutes
£11.99

Food Labelling Compliance: Essential Training for Businesses

By NextGen Learning

Compliance with food labelling regulations is critical to ensure transparency, consumer trust, and regulatory compliance. It encompasses principles, components, and nutrition information that forms the foundation of product labelling. Therefore, the industry demands professionals with a comprehensive understanding of food labelling and compliance requirements. Learning Outcomes: Understand the principles of food labelling in the UK Identify the components of a food label and their legal requirements Learn about nutrition labelling and its importance Gain knowledge of enforcement bodies and relevant legislation in the UK Comprehend UK regulations and laws on food labelling Understand the importance of public health and food safety in the food industry Food Labelling Compliance: Essential Training for Businesses is a comprehensive course designed to provide food industry professionals with an understanding of food labelling regulations in the UK. This theoretical course covers essential topics, such as the general principles of food labelling, the components of a food label, nutrition labelling, UK regulations and laws on food labelling, and public health and food safety. The course is delivered through various interactive materials, including quizzes, reading materials, and case studies. The course is suitable for anyone working in the food industry, from small business owners to food manufacturers. Upon completion of the course, participants will know to ensure their business complies with food labelling regulations, protecting the health and safety of their customers and avoiding costly legal penalties. Certification Upon completion of the course, learners can obtain a certificate as proof of their achievement. You can receive a £4.99 PDF Certificate sent via email, a £9.99 Printed Hardcopy Certificate for delivery in the UK, or a £19.99 Printed Hardcopy Certificate for international delivery. Each option depends on individual preferences and locations. CPD 10 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This course is ideal for the following: Small business owners in the food industry Food manufacturers Caterers Food importers Career path Some of the career paths related to this field are: Food Labelling Specialist: £25,000 - £40,000 Food Safety Manager: £30,000 - £45,000 Quality Control Manager: £35,000 - £50,000 Regulatory Affairs Manager: £40,000 - £65,000 Food Production Manager: £40,000 - £60,000 Food Technologist: £20,000 - £35,000

Food Labelling Compliance: Essential Training for Businesses
Delivered Online On Demand3 hours
£15

Drug Development and Regulation

By NextGen Learning

Are you fascinated by the inner workings of drugs and the process of getting them to market? Do you have a passion for pharmacology and want to gain a deep understanding of drug development and regulation processes? Our comprehensive Pharmacology course is the perfect fit for you! Unlock the secrets of drug development and regulation with our Pharmacology course. From fundamental principles to neuropharmacology and chemotherapy, gain a deep understanding of drug development and regulation processes. Learning outcomes: Gain a strong foundation in fundamental principles of pharmacology Understand the process of drug development and regulation Explore the applications of pharmacology in neurology, cardiology, endocrinology, chemotherapy, and immune pharmacology Develop an understanding of inflammation and immune pharmacology Acquire knowledge of the effects of drugs on the cardiovascular system and endocrine system Develop an understanding of the fundamental principles of toxicology Our comprehensive Pharmacology course offers a deep dive into the fundamental principles of pharmacology, drug development, and regulation. The course is designed to provide students with an understanding of the mechanisms of drug action, as well as the regulations governing drug development and approval. Students will explore the applications of pharmacology in various fields such as neurology, cardiology, endocrinology, chemotherapy, immune pharmacology, and toxicology. They will also learn about the impact of drugs on the cardiovascular and endocrine systems. The course is designed to equip students with the knowledge and skills required to enter the field of pharmacology. Our experienced faculty, coupled with a rich course curriculum, ensures that students gain a comprehensive understanding of the subject matter. Certification Upon completion of the course, learners can obtain a certificate as proof of their achievement. You can receive a £4.99 PDF Certificate sent via email, a £9.99 Printed Hardcopy Certificate for delivery in the UK, or a £19.99 Printed Hardcopy Certificate for international delivery. Each option depends on individual preferences and locations. CPD 10 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Students interested in pursuing a career in pharmacology Healthcare professionals seeking to expand their knowledge of pharmacology Anyone looking to gain an understanding of drug development and regulation processes Students pursuing a degree in pharmacology, medicine, or related fields Career path Pharmacologist (average salary of £33,000-£65,000 per year) Pharmaceutical Scientist (average salary of £20,000-£60,000 per year) Clinical Research Associate (average salary of £28,000-£45,000 per year) Toxicologist (average salary of £25,000-£50,000 per year) Regulatory Affairs Officer (average salary of £30,000-£50,000 per year) Drug Safety Associate (average salary of £25,000-£40,000 per year)

Drug Development and Regulation
Delivered Online On Demand3 hours
£15

Level 3 Certificate in HACCP Training

By Compliance Central

Imagine wielding the ultimate shield against foodborne hazards, ensuring every bite delights, not dismays. That's the power you unlock with our Level 3 HACCP Training. This comprehensive HACCP Trainingcourse empowers you to become a food safety champion, mastering the internationally recognized HACCP system - the gold standard in safeguarding public health. Dive deep into the science behind HACCP Training, unravelling the mysteries of microbiological, allergenic, chemical, and physical hazards lurking in food. Learn how to identify and control these threats at every stage, from farm to fork. We'll guide you through the HACCP framework, equipping you with the knowledge to establish, implement, and maintain robust food safety management systems. Forget jargon and dry lectures; our engaging program brings HACCP to life. Through interactive exercises and clear explanations, you'll grasp intricate concepts with ease. Level 3 Certificate in HACCP Training Course Learning Outcomes: Gain a deep understanding of HACCP principles and its significance in ensuring food safety. Identify and evaluate microbiological, allergenic, chemical, and physical hazards in food production. Develop the ability to implement HACCP prerequisites and preliminary steps effectively. Master the creation and maintenance of a robust HACCP system tailored to specific industry requirements. Acquire proficiency in applying the seven key principles of HACCP to prevent and control food safety hazards. Demonstrate competence in compliance with relevant legislation and regulations governing food safety protocols. Level 3 Certificate in HACCP Training Module 01: Introduction to HACCP and Legislation Module 02: Food Safety Microbiological Hazards Module 03: Food Safety: Allergenic, Chemical & Physical Hazards Module 04: HACCP Prerequisites, Preliminary Steps and Creation of HACCP System Module 05: The Seven HACCP Principles Explained Certificate of Achievement Endorsed Certificate of Achievement from the Quality Licence Scheme Learners will be able to achieve an endorsed certificate after completing the course as proof of their achievement. You can order the endorsed certificate for Free to be delivered to your home by post. For international students, there is an additional postage charge of £10. Endorsement The Quality Licence Scheme (QLS) has endorsed this course for its high-quality, non-regulated provision and training programmes. The QLS is a UK-based organisation that sets standards for non-regulated training and learning. This endorsement means that the course has been reviewed and approved by the QLS and meets the highest quality standards. Who is this course for? Level 3 Certificate in HACCP Training Who is this course for: Food Safety Officer Quality Assurance Manager Compliance Specialist Food Production Supervisor Regulatory Affairs Coordinator Requirements Level 3 Certificate in HACCP Training To enrol in this Level 3 Certificate in HACCP Training course, all you need is a basic understanding of the English Language and an internet connection. Career path Level 3 Certificate in HACCP Training Career Path: Food Safety Officer: £25,000 to £40,000 per year Quality Assurance Technician: £20,000 to £35,000 per year HACCP Coordinator: £25,000 to £45,000 per year Food Safety Consultant: £30,000 to £50,000 per year Compliance Manager (Food Industry): £35,000 to £60,000 per year Food Safety Auditor: £25,000 to £45,000 per year Certificates CPD Accredited PDF Certificate Digital certificate - Included QLS Endorsed Hard Copy Certificate Hard copy certificate - Included CPD Accredited Hard Copy Certificate Hard copy certificate - £9.99 CPD Accredited Hard Copy Certificate Delivery Charge: Inside the UK: Free Outside of the UK: £9.99 each

Level 3 Certificate in HACCP Training
Delivered Online On Demand4 hours
£100

Level 5 Diploma in Compliance Audit & Risk Management

By Compliance Central

Learn about Compliance Audit & Risk Management in our Level 5 Diploma in Compliance Audit & Risk Management course. Take in eight captivating lessons covering the fundamentals of compliance, the essential elements of a Compliance Management System (CMS), and the best approaches for carrying out compliance audits. You will also explore the ethical dimensions of compliance, and how to foster a culture of integrity and accountability within your organization. This course will equip you with the knowledge and skills you need to excel in Compliance Audit & Risk Management. If you want to learn how to ensure that your organization meets the standards and regulations of its industry, this course is for you. You will gain a comprehensive knowledge of Compliance Audit & Risk Management, covering essential topics such as Introduction to Compliance, Five Basic Elements of Compliance, Compliance Management System (CMS), Compliance Audit and Ethics, Risk and Types of Risk, Introduction to Risk Management, and Risk Management Process. By the end of this course, you will have a solid foundation in Compliance Audit & Risk Management, and be able to apply your skills and knowledge in real-world scenarios. CourseLearning Outcomes: Develop an in-depth understanding of Compliance Audit & Risk Management principles. Get comprehensive knowledge of the five basic elements of compliance. Master the intricacies of Compliance Management Systems (CMS). Demonstrate a profound grasp of Compliance Audit methodologies. Explore the nexus between Compliance and Ethics. Meet a nuanced understanding of various risks and the Risk Management process. Level 5 Diploma in Compliance Audit & Risk Management Module 01: Introduction to Compliance Module 02: Five basic elements of compliance Module 03: Compliance Management System (CMS) Module 04: Compliance Audit Module 05: Compliance and Ethics Module 06: Risk and Types of Risk Module 07: Introduction to Risk Management Module 08: Risk Management Process Certificate of Achievement Endorsed Certificate of Achievement from the Quality Licence Scheme Learners will be able to achieve an endorsed certificate after completing the course as proof of their achievement. You can order the endorsed certificate for Free to be delivered to your home by post. For international students, there is an additional postage charge of £10. Endorsement The Quality Licence Scheme (QLS) has endorsed this course for its high-quality, non-regulated provision and training programmes. The QLS is a UK-based organisation that sets standards for non-regulated training and learning. This endorsement means that the course has been reviewed and approved by the QLS and meets the highest quality standards. Who is this course for? This course will be particularly useful for: Compliance Analyst Risk Management Specialist Regulatory Compliance Officer Internal Auditor Corporate Ethics Consultant Compliance Manager Requirements To enrol in this Level 5 Diploma in Compliance Audit & Risk Management, Purchasing & Procurement course, all you need is a basic understanding of the English Language and an internet connection. Career path Our course will prepare you for a range of careers, including: Compliance Officer: £25,000 to £45,000 per year Risk Analyst: £30,000 to £50,000 per year Internal Auditor: £35,000 to £55,000 per year Regulatory Affairs Specialist: £30,000 to £50,000 per year Certificates CPD Accredited PDF Certificate Digital certificate - Included QLS Endorsed Hard Copy Certificate Hard copy certificate - Included CPD Accredited Hard Copy Certificate Hard copy certificate - £9.99 CPD Accredited Hard Copy Certificate Delivery Charge: Inside the UK: Free Outside of the UK: £9.99 each

Level 5 Diploma in Compliance Audit & Risk Management
Delivered Online On Demand3 hours
£109

Information Management and GDPR ( Data Protection)

By Imperial Academy

Level 3 - Two Endorsed Training | QLS Hard Copy Certificate Included | Plus 5 CPD Courses | Lifetime Access

Information Management and GDPR ( Data Protection)
Delivered Online On Demand
£300